DrDistillation

Were these USP grade as required?

That bulletin has been superseded and is no longer valid because people were having trouble understanding it. You must use denatured alcohol in the sanitizer period. You do not have to ship/transport denatured alcohol if you aren't producing the finished product. IE you give/sell undenatured alcohol that meets USP grade requirements to a local pharmacy or other DSP and they produce the finished product with other USP grade ingredients. But they (other party) will have to denature it. You MAY have to prove your spirit is USP grade as that is a requirement. If you transfer spirits not denatured to another party you MAY have to prove the spirit was used or pay tax on it. To be safe and clear, don't transfer any undenatured alcohol. You MUST register your company and product with the FDA prior to distributing product, etc... You must follow the bulletins, requirements and guidelines as specified. When you register with the FDA, read everything as well. Doing something wrong could cost you long term or cause you to loose your bond/DSP. Basically don't produce product if you don't fully understand the process. Neither the TTB or FDA plan on going after anyone making an effort to follow the guidelines and procedures, so make sure to do so. Be careful what you think are "relaxed regulations". DSPs are being allowed to register with the FDA and produce a product they are normally not BONDED to make, but that doesn't give you a free ride to change things up or do things your way regardless if you charge for it or donate it. Your product could be tested at any time. You must produce a USP grade product using ethanol which means you need to be able to produce USP grade ethanol. You're not recycling heads, etc. What you need to produce is technically cleaner than what many people produce for GNS use. Remember you are registering with the FDA to make a pharma class product and you must do this. Think about it this way. If you produce a product that has chemicals in it that cause a reaction to a person using your product YOU could be held responsible just as Purell or any other large company. To make this more clear a spirit like Everclear 190 would not be allowed to be used as it's not USP grade. Nowhere does anything ask DSP to absorb costs. There are many DSP contracting with states and cities or hospitals to produce. Some are partnering with grocery stores to sell products. Some are donating products as well. If you don't fully understand exactly what is required of you, don't jeopardize your DSP. Don't get involved producing sanitizer until you are 100% you meet all requirements and have the proper paper work and tracking in place. This is a great opportunity for DSP and AFP if done correctly but it only takes a bad apple or two doing things wrong to halt this for everyone.

And you need to make sure to purchase USP grade ingredients for denaturing as well.

I had the same question about ABV % but think the answer is here: From https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf "Hygienic handrub The microbicidal activity of the two WHO-recommended formulations was tested by WHO reference laboratories according to EN standards (EN 1500). Their activity was found to be equivalent to the reference substance (isopropanol 60% v/v) for hygienic hand antisepsis." Seems like they are trying to say that this "quick/easy formula" requires higher ABV to equal their reference substance therefore it must be made at 80%. But more importantly please make sure you understand that you can not produce sanitizer that is undenatured in the USA. Here is yesterday's bulletin: https://www.ttb.gov/public-guidance/ttb-pg-2020-1a "TTB’s March 18 authorization referred to both denatured and undenatured ethanol. However, on March 23, 2020, the FDA issued guidance which specifies the use of denaturants when compounding ethanol-based hand sanitizers." "TTB is therefore providing this guidance to (1) supersede its prior guidance with regard to the authorized formula to be consistent with FDA guidance; (2) exempt distilled spirits plants (DSPs) from the requirements to request approval from TTB to receive denatured or undenatured distilled spirits in bond from another DSP and to obtain additional bond coverage, through June 30, 2020; (3) provide guidance and certain exemptions from requirements for state and local governments wishing to obtain tax-free alcohol, and (4) offer hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions the same streamlined application process." This CLEARLY states you must denature the alcohol to make and distribute sanitizer. You can however purchase undenatured distilled spirit from a DSP but you MUST then denature it for production. The FDA doesn't want undenatured sanitizer being produced!

Cool, thanks for that. Missed it. I'll email them or find a contact.

You likely need to add other ingredients to this list that can be used to denature the alcohol. Most distillers won't have these ingredients on hand and need these to avoid paying taxes on the alcohol produced for the sanitizer. You should also provide a link for the mandatory registration with the FDA Drug Registration and Listing System BEFORE producing any sanitizer. To many people are likely going to have issues later without following the specific 6 step set of instructions and not following the footnotes to understand those steps that have been given by the TTB. Anything you can add to the portal will help to avoid these issues.

Just to make sure this is clear distillers in the USA must follow TTB rules and labeling exactly as written and pay tax if the alcohol was not prepared to United States Pharmacopoeia (USP) grade or wasn't denatured. WHO and FDA set guidelines. TTB sets rules and waivers that DSP & AFP must follow for Covid-19 production of sanitizer. If in the USA start with the TTB guidance listed here and make sure you comply. https://www.ttb.gov/public-guidance/other-public-guidance-documents

Here is a really good video that might teach you a lot about the distillation process talked about here. This is a video made for Shell about crude oil distillation but the process is very similar for many parts of the process. This gives a really good overview of distillation and how plates are used. Once you've watched this and have a good understanding of how this works you can search for specific videos on Youtube for vodka distillation or other spirits and understand what you are seeing much easier.

@Thatch it says pharmacies or Federal facilities. You are a federally bonded DSP with bond correct? This might make it easier to understand: https://www.ttb.gov/public-guidance/ttb-pg-2020-1a "Permit guidance for alcohol fuel plants (AFPs) and beverage DSPs: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption." Read that whole bulletin to make sure you understand it before producing. Feel free to ask any questions here. Keep an eye on this page for any updates: https://www.ttb.gov/public-guidance/other-public-guidance-documents

Are you guys doing your part by donating labels for sanitizer use to distilleries? DSPs are already loosing out on sales by diverting resources to making free sanitizer, plus footing the bill for labor, ingredients and bottles. Any help from other related industries would surely be appreciated I'm sure!

Well I was just asking a question. The difference between 80% and 70% is quite a bit and many more bottles could be produced from the same alcohol. (edit, I was looking at other products beside Purell when I wrote 65% before. It appears Purell is produced at 70%.) Purell and many other similar sanitizers have been the standard for a long time and don't get anywhere near the 80% ABV mark. The Centers for Disease Control and prevention recommends using a hand sanitizer with at least 60 percent alcohol. The FDA put out a publication https://www.fda.gov/media/136118/download using the formula many have repeated here but fail to see the footnote #6. "Consistent with the 1994 TFM, alcohol should be used in a final product concentration between 60-95% (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; isopropyl alcohol should be used in a concentration between 70-91.3% (v/v). This guidance is consistent with WHO’s recommended formulation specifications of 80% alcohol and 75% isopropyl alcohol." So is the WHO being overly high on the ABV needed or is the mass market of commercial sanitizers not really doing a proper job? I think this is a common sense thing to question and talk about. It also appears that a solution of 70% final ABV is fine to use as well according to WHO, FDA & CDC. A target of 70% vs 80% allows a lot more product to be made from the same base spirit.

EDIT: I read the label wrong, sorry it's actually 70% not 65% final. Was looking at multiple bottles from different suppliers. But it's still lower than what many are producing right now. Curious, how many of you guys have noticed the WHO formula targets 80% ABV but commercial sanitizer like Purell only start with only 70% ABV before adding other ingredients including water? "Ingredients: Active Ingredients: Ethyl Alcohol (70%) (v/v). Purpose: Antimicrobial. Inactive Ingredients: Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum)." Purell is basically selling a 65% or so formula while the WHO is pushing an 80% formula. Purell is the Canadian Club living in a cask strength world of sanitizers.

"Guidance" is key word in what you just said. Also the TTB has stated denatured or NOT denatured is allowed right now for production.

Add questions about guidance for reporting which really hasn't been given much detail and will cause problems later for many DSPs not sure of how to report transactions. Would the federal government be willing supply ingredients & bottles (maybe under FEMA) to DSPs who can supply equipment and labor to turn raw ingredients into products? After all the federal government should be able to purchase in massive bulk and transport it as well streamlining the process.

No idea how many bottles you need to make but if you have or can throw a keg reflux still together you could likely run this while doing other things. If you made a 15% sugar wash with enzymes and ran 14 gallons at a time you could produce approximately 5.5 to 6 liters a run on a keg still. Depending on work day could likely get 2 runs in even on a small Hobby size still and produce 11 to 12 liters of ethanol per day. If you follow the WHO recipe 1 from https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf you would end up with about of 6 liters of sanitizer per run. If you package that up in 8 oz to 250mL bottles of some kind you get 26 to 27 bottles from each run. Not going to be setting the world on fire but it's better than nothing and might be able to keep local police, fire fighters/rescue squads, etc in stock and allow them to divvy up what you produce. Of course those numbers could double if doing two runs a day on a hobby/home size still easily. This amount would be easy to keep up with fermentations using just a couple of brute trash cans you could use to not bother other operations. If you did 2 runs a day that's 50 bottles a day x 5 working days or 250 bottles a week. That's not insignificant in some communities as every bottles helps especially when it goes to the right people who have no choice but to be around other people. Of course if you have a bigger reflux still available the numbers climb quickly. If you have an old pot still you could strip first, then you could put higher ABV in the reflux still, etc... Keep in mind you don't have to be making 100 bottles an hour to be helping the community, just do what you can, using the equipment you already have or can throw together for this purpose quickly and see that the bottles you are making go to those who need it most. Just food for thought.

I don't see any new information there in the FDA release. Same regulations in 27 CFR parts 20 and 21 for denaturing. Same USP Purity grade of 94.9% alcohol. Did I miss something?

Nate, are you only a bottler or do you have any stills at all? If you own a still, you can make your own spirit to be used for this pretty easily. Even with a pot still you can do this. (just not as easily). You can actually produce it faster than normal spirits and you don't care about taste of the spirit and really don't need to worry about cuts per say. You might also be able to partner with local grocery stores for "free sugar" which is easier/faster to use than grains and work just fine for this as you can ferment at roughly 2-3x normal ABV you would do with grains. You could produce the most awful tasting spirit (think Everclear 190) this way but the ABV would be high enough to use for the sanitizer base since really only the ABV matters assuming you denature it. What kind of demand do you have for spirits, i.e. how much do you need? Probably more important do you have adequate bottles? This right now is a struggle for many as bottles are getting very hard to come by. Maybe consider self/serve refill stations where people bring there own bottles and you supply 5 gallon "carboys" at fill stations around you city (maybe partners who contribute ingredients).

Was your order not big enough for MGP? How much are you looking for? What region are you in as shipping might be the bulk of your cost.

Might be helpful to tell how many plates so they know what type of spirits it's designed for.

MGP or ultrapure should be checked. You can get samples from both. https://ultrapure-usa.com/services-2/distilleries-blenders-bottlers/ https://www.mgpingredients.com/distilled-spirits/beverage/product

I wouldn't think so either, but I'm not expert in these matters so I'd defer to those with more knowledge. Considering the fed gov is now allowing those with Alcohol Fuel Permits to make this they seem a bit "desperate" to get sanitizer out in the public so I'd not be to concerned and just "best case" denaturing for tax purposes and just not have extra around for any checks. It seems like the Fed Gov is going to be quite lenient anyway at this point. Follow guidelines as best you can. Don't forget to keep tight records of what you give away, costs and fair market value. It will help you next year at tax time, not that you're worried about it now but all the same, keep good records. If you make sanitizer, don't forget to reach out to local authorities like police force, rescue squad, nursing homes, but don't forget churches in your area as well as city counsel. While they themselves might not need it, they might be able to tell you who does. These are all good/great organizations/departments to have their support behind you. Don't forget the local liquor store as well for a distribution point. They will remember your generosity in times like this.

Nicely done by the TTB.

The short answer us unless you're bonded to do , your spirits can't be used, period. This was just talked about here:

Those little air stills are pretty much useless for making any real amount of spirit worth drinking IMHO. They are just to small, period. It's a math problem. For example a 10% boiler charge filled 3/4 full will produce about 1/4 a gallon at 25% give or take. So your first 3 runs are just to concentrate your alcohol. Now your 4th run to try and make some drinkable spirit starts off with about 3/4 gallon of 25%. You'll collect this into a few different containers so you can try and separate the good jars from the bad jars. It's slow and I doubt you'll want to stay close to change jars every 100 ml or so. But even if you did you'll likely have to discard the first 1/4 of the run and the last 1/4 of the run keeping the center 50%. Now you produced probably something like 1/5 of a gallon of spirits and you keep half of that or 1/10th gallon after 4 runs through the airstill. You would likely need to do about 5 steps of distillation to get something clean enough to be close enough to consider it a "home made" vodka in order to use it as a base for gin/Geneva (from a home perspective). But at this point you've only done 2 distillations and only have 1/10th of a gallon. The problem with small stills like this is that it's like riding a bike or walking up a hill. Going up the hill is the heads portion. When you get to the top there is a bit of level ground (hearts) then the backside of the hill (tails). With this super small still as soon as you reach the top you start back down the backside. Ideally you only want the flat ground (hearts) to use for the next distillation step and will reprocess the front and backside to get more hearts later. With a bigger still you can compress the front and backside a bit and get more level ground (hearts). Not only that but if you had a 5 gallon pot still you could fill it about 4 gallons full vs 3/4 gallon on your air still. That's about 5 1/3 more charge (fluid in the boiler) to work with. So now that you have more of the level ground will be approximately 5.5 times longer making it easier to identify the level ground (hearts). A 10 gallon still would be a bit better than twice as good as the 5 gallon still, etc... The bigger the home still to a point the easier it is to make decent spirits. I don't mean to crush your dreams but you would be best off trying to sell the airstill on ebay for $80 or so and take that money to Walmart and purchase a stainless steel 5 gallon pot and lid, a 5 gallon plastic buck and a 20-25 foot roll of 3/8 copper refrig copper water line. You can find a bunch of videos on youtube how to make a still and worm from those main components plus a few misc components. If you just want to purchase something I can point you to a good/decent Chinese heavy duty 5 gallon pot still that is one of my favorite stove top stills and can be used to make beer as well or heat up strike water for your mash or washes for $150 or so. If you had a 5 gallon pot still you could load it up about 4 gallons full. 4 Gallons of 10% = 0.4 gallons of pure spirit available in 1/2 the time to boot. However if you strip that 4 gallons and do this 3 times you'll have enough to fill the pot still again this time with 25% or so ABV for a spirit run. 4 gallons of 25% = 1 gallon of pure spirit potential in less distillation time. See where I'm going with this? Assuming you keep half of this (hearts) then you'll set aside about 25% heads (uphill) and 25% tails (downhill) for another spirit run and reprocess this later. You now have roughly 1/2 gallon of pure spirits from the 2nd distillation/spirit run on a pot still. You probably have one long day or a weekend at this point to get this. Repeat this process the next weekend again but this time add in your "discarded feints" (heads/tails) during the strip runs. Take your 3 strip runs and do a spirit run again from this. You'll end up with more spirit this week then the first week due to the feints you added. You'll also set aside this weeks feints so you can reprocess them again. Combine the two batches (last week and this week), dilute to 40% and run it again. Take only the clean middle cut you get from this run, Set aside the heads/tails for reprocess again later (never goes to waist so don't be greedy and only take the clean middle portion). You now have a decent amount of high proof spirits in the range of 70 to 80%. Filter this through carbon a few times to clean it up and you can make a lot of things from it like vodka, gin, aqua vitea, apple pie moonshine, limoncello, etc. Point being the 5 gallon still on your stove will run as fast or faster then your airstill, produce far more and give you better control. You can use 5 gallon plastic buckets to ferment in (one bucket per strip run) or just pickup a 20 gallon brute trashcan to ferment in. The 5 gallon buckets are easy enough to hide in closets while fermenting and the 5 gallon pot still can be broken down when not in use and stored as normal pot under the sink when not in use. If anyone sees it or asks about it you distill water. I'm sure most of the people here on this forum wouldn't consider what you make "vodka" as it was never distilled to 190+ proof but that's only a government rule/method to ensure the spirit is at least clean enough to be called neutral. You can produce just as good final product distilling at 160 to 170 proof and carbon filtering a few times at the home level. But realistically you need a bigger boiler charge to start with to have a fighting chance of making something decent/passable and I'd suggest at least a 5 gallon pot (bigger is better/easier) you can run on a stove. PS at the home level depending on the spirits being made you can use freeze distillation to your advantage. Clear out a shelf in the freezer and fill 2 or 3 gallon plastic soda bottles with wash after ferment. Stick them in the freezer or outside if freezing and let them freeze. Now flip upside to drain in a bucket or glass. The liquor will come out first with ice and ice crystals remaining the bottle. Yeast and other sediment will also be trapped in the ice/bottom. If you do this 2 or 3 times you can easily raise your 10% ferment to 25% or 30% without ever running your still replacing the strip run (airstill or 5 gallon pot still). At the home level I do this quite often using 5 gallon plastic carboys in the winter. I just set them outside to freeze. I took the lid of a 5 gallon bucket and drilled a hole in it so I can flip the carboy upside down to drain in it. Same with other lids for 2 and 3 liter soda bottles, just smaller holes to accommodate the soda bottles. I can drain 4 bottle into a bucket the same way (using the freezer in summer). Sometimes it's easy to strip using a still, sometimes it's easier to freeze distill depending on what's going on in life. It doesn't take long to take 4 3 liter bottles from the freezer and flip them upside down on a 5 gallon bucket then check them in 30 minutes or so to know when only ice is left (water). Back in the colonial days, NJ was known for the Hard cider or Apple Jack. They took 6 to 8% ferments of apples, stored them in barrels and let it freeze outside in the winter. They would lift out the ice that formed (frozen water) and repeat the process during the winter. By spring they had 30 to 35% hard apple jack.. Of course it was never distilled so all the compounds that give you a headache/hangover were never removed (actually concentrated) so you could feel like you had "apple pausie" the next day (wicked hangover) if you drank a lot of it. But this is a cool way to avoid strip runs on home spirits, just take a generous foreshot/heads cut to remove those "headache" producing spirits and skip the strip runs on the still.

Don't forget to temperature correct your SG. For example if you pull it out hot and get a measurement of 1.060 at 150 F you really have a 1.078 SG. I typically would fill a large tube and let it settle as well as cool which helps to get more accurate readings.